510(k) K141398 ยท NKB Thoracolumbosacral Pedicle Screw System
PASS LP SPINAL SYSTEM
| Applicant | Medicrea International SA, Neyron, FR |
| Decision | Substantially Equivalent, Jan 9, 2015 |
| Received | May 28, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K141398
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 27, 2019 | Medicrea International Medicrea Pass LP, REF B02217545, Non Sterile, Material: Ti-6Al-4V ELI, VIS PEDICULAIRE POLYAXIALE 7.5MM x 45MM, POLYAXIAL PEDICLE SCREW 7.5MM x 45 MM, POLYAXIAL PEDIKELSCHRAUBE 7.5MM X 45MM, TORNILLO Terminated |
NKB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.